PovertyNCT05091957
Connecting Families
A study testing Community Support Worker in people with Poverty and Primary Care, run by Queen's University at 1 site in Canada.
Trial summary
Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Read more about this study
- Who is it for?
- Ages 1 day to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Poverty, Primary Care, Intervention
- What is being tested?
- Community Support Worker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 17 May 2022to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of children (younger than 3 years) attending a regularly scheduled primary care visit.
- Parents respond affirmatively to the question "Do you ever have difficulty making ends meet at the end of the month?"
- Informed parental consent. Only one child will be enrolled per family. For families with more than one child, we will enroll the youngest eligible child, since literature suggests that impact of reducing family stress may be greater at younger ages; for multiple births, one child will be randomly selected for inclusion.
Who cannot join
- Parents without legal status in Canada, as they are not eligible for many Canadian social programs.
- Families who are receiving system navigation support, such as from a social worker or public health nurse, or who have received system navigation support within one year prior to enrolment.
- Child with a previously diagnosed developmental disorder, genetic, chromosomal or syndromic condition.
- Child born prematurely (gestational age less than 32 weeks).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Queen's Family Health Team
Kingston, Ontario, K7L 5E9
Dane Mauer-Vakil, 613-533-9303, vdm@queensu.ca
About this study
Official title: CONNECTING FAMILIES: A Randomized Controlled Trial of Primary Care Poverty Screening and Financial Support Navigation for Families of Young Children
Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Many low income families may not be receiving all the social benefits for which they are eligible. There are calls for primary care providers to ask patients if they have difficulty making ends meet at the end of the month and to intervene if poverty is identified, but it is not known if intervening can improve parent's and children's health. This study will test whether a Community Support Worker who helps families with young children navigate the social service system by reviewing social needs (like food, housing or energy insecurity) and income supports can lead to increased family income, reduced parenting stress and an improvement in their child's health. The Community Support Worker will help families complete income tax, apply for benefits and community supports for which they are eligible. The investigators will also study the effect of this intervention on health care utilization. Our study will be conducted in Toronto and Kingston in primary care practices participating in the TARGet Kids! primary care research network. Results from this study will help health care providers and policy makers understand whether Community Support Workers are an effective way to integrate the health and social service systems to improve parent and child health.
Read the detailed description
INTRODUCTION AND IMPORTANCE: Poverty and financial strain have profound and long-lasting negative impacts on both parent and child health, contributing to substantial health disparities. As the first contact with the health system for most families, primary care providers are uniquely positioned to address child poverty in clinical settings.
Many professional health organizations recommend that healthcare providers identify and address social determinants of health, but there is little evidence regarding the impact of effective interventions. Social systems are frequently complex and difficult to navigate; for example, low income Canadians are known to have lower tax filing rates than the general population. Therefore, many families may not be accessing all social benefits to which they are entitled. The investigators propose to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care using a randomized controlled trial to evaluate the impact on parent and child health outcomes. Results of our pilot study demonstrated feasibility and will inform our proposed full trial.
METHODS: Study Design: A multi-site, pragmatic, blinded, superiority, parallel-group randomized controlled trial will be conducted.
Participants: Families of children ages (from birth to 2 years), screening positive for the question "Do you ever have difficulty making ends meet at the end of the month?", identified as a good predictor of poverty.
Intervention and Active Comparator: Families will be randomly allocated to the intervention or active comparator group. Parents in the intervention group will have a review of their social needs and resources with a trained Community Service Worker (CSW) with a thorough understanding of potential income supports and community agencies and will assist the parent to access financially related social benefits for which they are eligible. All participants will receive a written summary of available resources.
Outcomes: The primary outcome, measured 6 months after enrollment, is parenting stress, as measured by the Parenting Stress Index-Short Form. Secondary outcomes are change in: a) self-reported after-tax household income; b) household food security; c) parent depression; d) child development; e) child social, emotional and behavioural health; f) Community Service Worker workload; g) health care utilization.
TEAM EXPERTISE: The study is a collaboration between TARGet Kids!, (a well-established child-focused primary care practice-based research network) and integrated Knowledge Users (parents, administrators and policy makers). The research team has expertise in child health, pragmatic trials and social determinants of health.
EXPECTED OUTCOME: Results from this research will address a critical evidence gap regarding a feasible and scalable intervention to address child poverty in the primary care practice setting. Leveraging primary preventive care in early childhood, which is accessed by almost all families, will provide powerful opportunities for implementation. Effective interventions to address child poverty and financial strain in clinical practice have the potential to influence child health trajectories over their life course.
- Conditions
- Poverty, Primary Care, Intervention
- Being tested
- Community Support Worker, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Support WorkerOther
structured review of participant income supports with a trained CSW, to identify financial needs and benefits for which the family is eligible, including assessment of income and food security, affordability of medications, housing and energy insecurity, and dental care. The visits will be conducted in person, by telephone or by videoconferencing, according to participant preference and to ensure adherence to COVID-19 pandemic-related criteria.
Usual CareOther
Participants in both groups will receive a written summary of available resources
| Study group | Role | What they receive |
|---|---|---|
| Community Support Worker | Experimental | structured review of participant income supports with a trained CSW, to identify financial needs and benefits for which the family is eligible, including assessment of income and food security, affordability of medications, housing and energy insecurity, and dental care. The visits will be conducted in person, by telephone or by videoconferencing, according to participant preference and to ensure adherence to COVID-19 pandemic-related criteria. Receives: Other: Community Support Worker |
| Usual Care | Active comparator | There is no clear standard of care and potential for practice variation in clinician responses to identified social need. Based on the ethical imperative to provide some support to families who identify unmet social needs, the comparator group will receive Usual Care, defined as: Participants in both groups will receive a written summary of available resources. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress Index- Short Form 4
A 36-item parent-completed questionnaire assessing overall level of stress a person is feeling in their role as a parent. Scoring yields an overall stress score (range 36-180, with higher scores indicating greater stress) and sub-scores for Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child (each with range of 5-60) which are summed to generate the total score. .
Measured: 6 months
Secondary outcomes (10)
Self Reported Household Income
Self Reported Household Income from all sources
Measured: 6 months, 12 months
Participant use of community resources
This is a study specific instrument which assesses participants' receipt of a comprehensive suite of financial benefits (including specific income tax benefits, benefits through social assistance programs) and receipt of emergency food services, childcare subsidy, energy assistance, support for medication and dental costs and housing needs.
Measured: 6 months, 12 months
Household food security
18-item Household Food Security Survey Module, asks about the household's experiences of food insecurity during the previous year. Higher scores indicate increased food insecurity and households are classified as food secure, marginally food insecure, moderately food insecure or severely food insecure.
Measured: 6 months, 12 months
Social Needs
WE Care Survey, s a 10-item questionnaire assessing needs in 4 domains (economic stability, education, neighborhood \& physical environment, and food) and whether participants want help with identified needs..
Measured: 6 months, 12 months
Parent Depression
Patient Health Questionnaire - 9, a 9 item self completed instrument measuring symptoms of depression (range 0-27 with higher scores indicating worse outcome).
Measured: 6 months, 12 months
Parent anxiety
Generalized Anxiety Disorders-7, a 7 item self completed instrument measuring symptoms of anxiety (range 0-21, with higher scores indicating worse outcome).
Measured: 6 months, 12 months
Child Social- Emotional Development
Ages and Stages: Social Emotional, age specific parent completed questionnaires assessing the child's social and emotional development, in which higher scores indicate better outcomes.
Measured: 6 months,12 months
Child general development
Ages and Stages-3: age specific parent completed questionnaires assessing the child's s development in 5 developmental areas (Communication, Gross Motor, Fine Motor, Problem Solving, Personal Social), in which higher scores indicate better outcomes.
Measured: 6 months, 12 months
Pediatric health system utilization
Through linkage with health administrative databases, the investigators will assess differences in health services utilization. The following administrative databases will be used: Ontario Health Insurance Plan (OHIP) which includes physician billings (fee for service and shadow billing) for physician visits, the National Ambulatory Care Reporting System (NACRS) which includes data on emergency department visits, and the Discharge Abstracts Database (DAD) which includes data on inpatient hospitalizations. We will assess between-group differences in primary care visits, low acuity emergency department visits (CTAS 3-5), number of hospitalizations and length of stay.For children, primary care visits will be categorized as well-child visits (which may appropriately increase) and other visits (which may be reduced).
Measured: 6 months, 12 months
Parent health system utilization
Through linkage with health administrative databases, the investigators will assess differences in health services utilization. The following administrative databases will be used: Ontario Health Insurance Plan (OHIP) which includes physician billings (fee for service and shadow billing) for physician visits, the National Ambulatory Care Reporting System (NACRS) which includes data on emergency department visits, and the Discharge Abstracts Database (DAD) which includes data on inpatient hospitalizations.We will assess between-group differences in primary care visits, low acuity emergency department visits (CTAS 3-5), number of hospitalizations and length of stay.
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start17 May 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PovertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centred, pragmatic, 1:1 allocation, parallel-group superiority randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imaan Bayoumi, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091957
- Sponsor's protocol ID
- FMED-6797-21
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data relevant to the study will be made available upon reasonable request to the principal investigators.
Publications
Bayoumi I, Parkin PC, Tabassum F, Johnson C, Sherwood M, Mitchell M, Birken CS, Bloch G, Carsley S, Cole M, Green M, Keown-Stoneman CDG, Maguire JL, Purkey E, van den Heuvel M, Weir S, Wong P, Borkhoff CM. Connecting families-randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol. BMJ Open. 2026 Feb 6;16(2):e111158. doi: 10.1136/bmjopen-2025-111158.
PubMed 41651520
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONNECTING FAMILIES: A Randomized Controlled Trial of Primary Care Poverty Screening and Financial Support Navigation for Families of Young Children
- ClinicalTrials.gov ID
- NCT05091957
- Acronym / sponsor ID
- FMED-6797-21
- Conditions
- Poverty, Primary Care, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Many low income families may not be receiving all the social benefits for which they are eligible. There are calls for primary care providers to ask patients if they have difficulty making ends meet at the end of the month and to intervene if poverty is identified, but it is not known if intervening can improve parent's and children's health. This study will test whether a Community Support Worker who helps families with young children navigate the social service system by reviewing social needs (like food, housing or energy insecurity) and income supports can lead to increased family income, reduced parenting stress and an improvement in their child's health. The Community Support Worker will help families complete income tax, apply for benefits and community supports for which they are eligible. The investigators will also study the effect of this intervention on health care utilization. Our study will be conducted in Toronto and Kingston in primary care practices participating in the TARGet Kids! primary care research network. Results from this study will help health care providers and policy makers understand whether Community Support Workers are an effective way to integrate the health and social service systems to improve parent and child health.
Detailed description
INTRODUCTION AND IMPORTANCE: Poverty and financial strain have profound and long-lasting negative impacts on both parent and child health, contributing to substantial health disparities. As the first contact with the health system for most families, primary care providers are uniquely positioned to address child poverty in clinical settings.
Many professional health organizations recommend that healthcare providers identify and address social determinants of health, but there is little evidence regarding the impact of effective interventions. Social systems are frequently complex and difficult to navigate; for example, low income Canadians are known to have lower tax filing rates than the general population. Therefore, many families may not be accessing all social benefits to which they are entitled. The investigators propose to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care using a randomized controlled trial to evaluate the impact on parent and child health outcomes. Results of our pilot study demonstrated feasibility and will inform our proposed full trial.
METHODS: Study Design: A multi-site, pragmatic, blinded, superiority, parallel-group randomized controlled trial will be conducted.
Participants: Families of children ages (from birth to 2 years), screening positive for the question "Do you ever have difficulty making ends meet at the end of the month?", identified as a good predictor of poverty.
Intervention and Active Comparator: Families will be randomly allocated to the intervention or active comparator group. Parents in the intervention group will have a review of their social needs and resources with a trained Community Service Worker (CSW) with a thorough understanding of potential income supports and community agencies and will assist the parent to access financially related social benefits for which they are eligible. All participants will receive a written summary of available resources.
Outcomes: The primary outcome, measured 6 months after enrollment, is parenting stress, as measured by the Parenting Stress Index-Short Form. Secondary outcomes are change in: a) self-reported after-tax household income; b) household food security; c) parent depression; d) child development; e) child social, emotional and behavioural health; f) Community Service Worker workload; g) health care utilization.
TEAM EXPERTISE: The study is a collaboration between TARGet Kids!, (a well-established child-focused primary care practice-based research network) and integrated Knowledge Users (parents, administrators and policy makers). The research team has expertise in child health, pragmatic trials and social determinants of health.
EXPECTED OUTCOME: Results from this research will address a critical evidence gap regarding a feasible and scalable intervention to address child poverty in the primary care practice setting. Leveraging primary preventive care in early childhood, which is accessed by almost all families, will provide powerful opportunities for implementation. Effective interventions to address child poverty and financial strain in clinical practice have the potential to influence child health trajectories over their life course.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multi-centred, pragmatic, 1:1 allocation, parallel-group superiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Community Support Worker | Experimental | Other: Community Support Workerstructured review of participant income supports with a trained CSW, to identify financial needs and benefits for which the family is eligible, including assessment of income and food security, affordability of medications, housing and energy insecurity, and dental care. The visits will be conducted in person, by telephone or by videoconferencing, according to participant preference and to ensure adherence to COVID-19 pandemic-related criteria. |
| Usual Care | Active comparator | Other: Usual CareThere is no clear standard of care and potential for practice variation in clinician responses to identified social need. Based on the ethical imperative to provide some support to families who identify unmet social needs, the comparator group will receive Usual Care, defined as: Participants in both groups will receive a written summary of available resources. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents of children (younger than 3 years) attending a regularly scheduled primary care visit.
- Parents respond affirmatively to the question "Do you ever have difficulty making ends meet at the end of the month?"
- Informed parental consent. Only one child will be enrolled per family. For families with more than one child, we will enroll the youngest eligible child, since literature suggests that impact of reducing family stress may be greater at younger ages; for multiple births, one child will be randomly selected for inclusion.
Key exclusion criteria (4 listed)
- Parents without legal status in Canada, as they are not eligible for many Canadian social programs.
- Families who are receiving system navigation support, such as from a social worker or public health nurse, or who have received system navigation support within one year prior to enrolment.
- Child with a previously diagnosed developmental disorder, genetic, chromosomal or syndromic condition.
- Child born prematurely (gestational age less than 32 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Support Workerstructured review of participant income supports with a trained CSW, to identify financial needs and benefits for which the family is eligible, including assessment of income and food security, affordability of medications, housing and energy insecurity, and dental care. The visits will be conducted in person, by telephone or by videoconferencing, according to participant preference and to ensure adherence to COVID-19 pandemic-related criteria. | Other | Community Support Worker |
| Usual CareParticipants in both groups will receive a written summary of available resources | Other | Usual Care |
Primary outcome
Parenting Stress Index- Short Form 4
Time frame: 6 months
A 36-item parent-completed questionnaire assessing overall level of stress a person is feeling in their role as a parent. Scoring yields an overall stress score (range 36-180, with higher scores indicating greater stress) and sub-scores for Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child (each with range of 5-60) which are summed to generate the total score. .
10 secondary outcomes
Self Reported Household Income
Time frame: 6 months, 12 months
Participant use of community resources
Time frame: 6 months, 12 months
Household food security
Time frame: 6 months, 12 months
Social Needs
Time frame: 6 months, 12 months
Parent Depression
Time frame: 6 months, 12 months
Parent anxiety
Time frame: 6 months, 12 months
Child Social- Emotional Development
Time frame: 6 months,12 months
Child general development
Time frame: 6 months, 12 months
Pediatric health system utilization
Time frame: 6 months, 12 months
Parent health system utilization
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 41651520Bayoumi I, Parkin PC, Tabassum F, Johnson C, Sherwood M, Mitchell M, Birken CS, Bloch G, Carsley S, Cole M, Green M, Keown-Stoneman CDG, Maguire JL, Purkey E, van den Heuvel M, Weir S, Wong P, Borkhoff CM. Connecting families-randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol. BMJ Open. 2026 Feb 6;16(2):e111158. doi: 10.1136/bmjopen-2025-111158.
- Individual participant dataSharing planned: Yes. All deidentified data relevant to the study will be made available upon reasonable request to the principal investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Support Worker in people with Poverty and Primary Care, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imaan Bayoumi (613-331-2371, bayoumi@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress Index- Short Form 4 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.